1. Field of the Invention
The present invention relates generally to blood flow assistance. More specifically, the present invention relates to devices and methods for extra-vascular blood flow assistance.
2. Background of the Invention
Maintaining proper blood flow is one of the basic tenets of promoting good health. The heart, being the primary organ responsible for the driving force of blood flow, has the heavy burden of incessantly pumping small volumes of blood in an endless loop within the circulatory system. Thus, it should be expected that any event that affects the proper functioning of the heart would, in turn, affect proper blood flow through the circulatory system, which, in turn, will affect body health. Such events that affect proper heart pumping function include, for example, congenital heart defects, accidents, and various types of surgery.
For example, in one such event, cardiac surgery, the heart often is at least partially damaged so as to need assistance in being able to increase in strength in order to perform its proper pumping function. For example, low cardiac output syndrome following cardiac surgery is not uncommon, and may be caused by impaired cardiac performance due to left, right or biventricular failure.
Despite conventional pharmacologic treatment, some patients having had such procedures require the use of mechanical cardiac support to treat cardiac failure. For adult patients, conventional choices for mechanical cardiac support include, for example, the intra-aortic balloon pump (“IABP”) and the ventricular assist device (“VAD”). For children and infants, options are much more limited.
Application of the IABP for infants has a number of drawbacks, including limited hemodynamic effectiveness, difficulty in application, and limited availability. Utilizing a pediatric VAD or extracorporeal life support (“ECLS”) may provide greater hemodynamic benefit than the pediatric IABP, but requires expensive equipment, specially trained personnel to deal with the complicated machinery, and has even more limited availability than the pediatric IABP.
The limited effectiveness, technical difficulty, complexity and expense associated with current technology result in suboptimal clinical success for many patients, particularly in pediatric cases. Thus, there is a need for an easy to use, versatile and inexpensive system that provides blood flow assistance that is needed without suffering from the drawbacks of conventional blood flow systems.